Jan Krhut1,2, Peter Wohlfahrt3, Jiří Pudich4, Eliška Kufová4, Vladimír Borovička5, Karolína Bílková6, Radek Sýkora7,8, Jan Mokriš5, Renata Cífková3, Roman Zachoval5, Peter Zvara9,10. 1. Department of Urology, University Hospital, Tř. 17. listopadu 1790, 708 52, Ostrava, Czech Republic. jan.krhut@fno.cz. 2. Department of Surgical Studies, Medical Faculty, Ostrava University, Ostrava, Czech Republic. jan.krhut@fno.cz. 3. Center for Cardiovascular Prevention, 1st Faculty of Medicine of Charles University and Thomayer Hospital, Prague, Czech Republic. 4. Department of Cardiology, University Hospital, Ostrava, Czech Republic. 5. Department of Urology, 3rd Faculty of Medicine of Charles University and Thomayer Hospital, Prague, Czech Republic. 6. Spinal Cord Rehabilitation Unit, Rehabilitation Center, Kladruby, Czech Republic. 7. Department of Urology, University Hospital, Tř. 17. listopadu 1790, 708 52, Ostrava, Czech Republic. 8. Department of Surgical Studies, Medical Faculty, Ostrava University, Ostrava, Czech Republic. 9. Department of Clinical Research, Biomedical Laboratory and Research Unit of Urology, University of Southern Denmark, Odense, Denmark. 10. Department of Urology, Odense University Hospital, Odense, Denmark.
Abstract
PURPOSE: To analyze cardiovascular safety of mirabegron in patients with spinal cord injury (SCI)- and multiple sclerosis (MS)-induced neurogenic detrusor overactivity (NDO) in a prospective, randomized, double-blind, placebo-controlled study. METHODS:Seventy-eight patients were enrolled into the study, and 66 of them were included into the final analysis. In 49 (74.2%), NDO developed due to suprasacral SCI, 17 (25.8%) suffered from NDO due to MS. Eleven patients were previously treated for hypertension and one for arrhythmia. All study participants received placebo for 2 weeks run-in period. Subsequently, eligible subjects were randomized for 4 weeks of active treatment with mirabegron 50 mg once daily (Group A; n = 32) or placebo (Group B; n = 34). Data from resting electrocardiography (ECG), 24-h ECG and blood pressure monitoring, and echocardiographic examination, were used for cardiovascular safety assessment. All reported variables were evaluated at time of randomization and at the end of the study. Longitudinal changes of variables within the groups and differences between the groups were assessed using nonparametric Kruskal-Wallis test, and p ≤ 0.05 was considered statistically significant. RESULTS: No statistically significant longitudinal changes were found in safety variables, except for prolongation of QT interval in placebo group (p = 0.0328) recorded by resting ECG. No significant difference between the Groups A and B, in any of the variables, was observed. A single cardiovascular study drug-related adverse event was recorded in a patient with cervical SCI (3.13%). CONCLUSIONS: Our results suggest that mirabegron can be safely used in the treatment of patients with SCI- and MS-induced NDO.
RCT Entities:
PURPOSE: To analyze cardiovascular safety of mirabegron in patients with spinal cord injury (SCI)- and multiple sclerosis (MS)-induced neurogenic detrusor overactivity (NDO) in a prospective, randomized, double-blind, placebo-controlled study. METHODS: Seventy-eight patients were enrolled into the study, and 66 of them were included into the final analysis. In 49 (74.2%), NDO developed due to suprasacral SCI, 17 (25.8%) suffered from NDO due to MS. Eleven patients were previously treated for hypertension and one for arrhythmia. All study participants received placebo for 2 weeks run-in period. Subsequently, eligible subjects were randomized for 4 weeks of active treatment with mirabegron 50 mg once daily (Group A; n = 32) or placebo (Group B; n = 34). Data from resting electrocardiography (ECG), 24-h ECG and blood pressure monitoring, and echocardiographic examination, were used for cardiovascular safety assessment. All reported variables were evaluated at time of randomization and at the end of the study. Longitudinal changes of variables within the groups and differences between the groups were assessed using nonparametric Kruskal-Wallis test, and p ≤ 0.05 was considered statistically significant. RESULTS: No statistically significant longitudinal changes were found in safety variables, except for prolongation of QT interval in placebo group (p = 0.0328) recorded by resting ECG. No significant difference between the Groups A and B, in any of the variables, was observed. A single cardiovascular study drug-related adverse event was recorded in a patient with cervical SCI (3.13%). CONCLUSIONS: Our results suggest that mirabegron can be safely used in the treatment of patients with SCI- and MS-induced NDO.
Authors: Elie El Helou; Chris Labaki; Roy Chebel; Jeanine El Helou; Georges Abi Tayeh; Georges Jalkh; Elie Nemr Journal: World J Urol Date: 2019-12-05 Impact factor: 4.226
Authors: Valentin Titus Grigorean; Aurelia Mihaela Sandu; Mihai Popescu; Mihai Aurelian Iacobini; Rares Stoian; Catalin Neascu; Victor Strambu; Florian Popa Journal: J Med Life Date: 2009 Apr-Jun